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Pfizer’s decision Wednesday to pull its sickle cell pill off the market because of safety concerns shocked advocates and doctors, leaving many searching for answers and scrambling for ways to notify their patients about a drug that has long divided the community. The move underscored the severity of the risks recently seen in studies of the drug, Oxbryta , in which researchers have reported a number of deaths among patients who were receiving it.
For decades, doctors caring for people with schizophrenia have relied on mood-regulating drugs that target the brain chemical dopamine. On Thursday, the Food and Drug Administration approved for the first time a new type of medicine that may change the way the psychiatric disorder is treated. The drug, called Cobenfy, will be sold by Bristol Myers Squibb.
Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.
This month, Apple launched a feature for the Apple Watch that alerts users if it determines they may have sleep apnea, potentially leading to treatment for a dangerous health condition that often goes undiagnosed. Some see this as a good thing: Untreated sleep apnea, a condition where breathing is repeatedly disrupted during sleep, can result in persistent daytime tiredness and in the worst cases, cardiovascular diseases that hasten death.
Biden administration officials have abandoned their own proposal to require drug companies to disclose the prices and research costs of drugs that are driving up spending in state Medicaid programs. Pharmaceutical companies and lobbying groups heavily pressured the Centers for Medicare and Medicaid Services to abandon the little-noticed idea to create “drug price verification surveys” — they indirectly threatened to sue if the government moved forward with it.
SILVER SPRING, Md. — Food additives rarely face FDA scrutiny once they’re on the market, even those with mounting evidence of safety concerns. At a meeting held by the Food and Drug Administration on Wednesday, regulators said they plan to change that. The public meeting on the FDA’s campus drew dozens of food safety advocates, industry representatives, concerned citizens, and state and federal lawmakers.
In testing, Cobenfy eased schizophrenia symptoms without some of the disruptive side effects typical of existing drugs. The results have been met with excitement, as well as caution.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Facing charges from the Securities and Exchange Commission for misleading claims related to a controversial Alzheimer’s drug candidate, Cassava Sciences and two of the company’s former executives have agreed to pay fines, the company announced Thursday. The news comes on the same day that the SEC filed charges against Cassava, former CEO Remi Barbier, and former senior vice president of neuroscience Lindsay Burns.
Despite working in a restrictive funding climate, the prolific startup creator is “in the ‘taking lots of risk’ mode,” said co-founder and managing director Robert Nelsen.
On Wednesday, Congress passed a temporary spending bill that keeps the government funded beyond Sept. 30. Yet, even in light of lawmakers averting a shutdown, there is another end-of-moth deadline looming they’ve largely ignored: expiration of foundational aging and disability legislation called the Older Americans Act (OAA). The OAA supports the delivery of home and community-based social and services that improve the lives, dignity, safety and wellbeing of older adults.
Our periodic round-up of financings in the biotech sector is led by an impressive nine-figure round for UK vaccines developer Vicebio, with GC Therapeutics, Genespire, and 858 Therapeutics also in on the action.London, UK-based Vicebio raised $100 million in a Series B that will help to fund the development of its Molecular Clamp technology to produce improved, more potent vaccines that are simpler to manufacture.
Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.
Epic Systems is no stranger to the courtroom. The nation’s largest vendor of electronic health records has fought, and won, legal fights with rivals large and small for many decades. But a new antitrust lawsuit filed this week by Particle Health , an upstart health data company, presents an especially direct threat to Epic’s dominance in the multi-billion dollar market surrounding patient data, legal and health policy experts told STAT.
MSD's combination of PD-1 inhibitor Keytruda and experimental LAG-3 inhibitor favezelimab has failed a phase 3 trial in patients with previously treated PD-L1-positive microsatellite stable (MSS) metastatic colorectal cancer.An analysis of data from the 447-patient KEYFORM-007 study revealed that the fixed-dose combination of Keytruda (pembrolizumab) and favezelimab was unable to extend overall survival (OS) compared to standard care with kinase inhibitor regorafenib and trifluridine and tipirac
This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox. The deep financial restructuring announced by Bluebird Bio this week offered another reminder that groundbreaking genetic medicines capable of transforming the lives of people with inherited disease are not now — and may never become — a sustainable business.
AstraZeneca's EGFR inhibitor Tagrisso has been approved by the FDA for a new lung cancer indication that could make it a go-to therapy for a patient population that until now had no targeted treatments. The US regulator has cleared Tagrisso (osimertinib) for patients with stage 3 non-small cell lung cancer (NSCLC) expressing EGFR exon 19 or exon 21 (L858R) mutations that cannot be treated with surgery and has been previously treated with chemoradiotherapy.
Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.
ARCH Venture Partners has raised $3 billion for a new fund — one of the largest in the biotech industry, and one the VC firm will use to continue its contrarian investment strategy. The last few years have tested many venture firms: biotech stocks dropped, valuations shifted, and the flow of fresh capital forced many startups out of business before signs of a recovery emerged.
Some Local Pharmaceutical Committees (LPCs) have secured funding to ‘facilitate direct engagement’ between pharmacies and GP practices around Pharmacy First, according to a new report from the Company Chemists’ Association. The funding from NHS England regions and integrated care systems (ICSs) has been used by one LPC to fund full-time staff to support engagement around […] The post Some LPCs securing funding for Pharmacy First 'engagement' appeared first on The Pharmacist.
Within a few days of one another, two teams of accountants released separate estimates on the value of nonprofit hospitals’ tax exemptions. Their wildly different findings underscore the degree to which who’s counting and what they count matters. The first, a JAMA study published today , pegged that number at $37.4 billion. It factored in the value of forgone federal and state income taxes, sales tax, property tax, federal unemployment tax, charitable contributions from donor
BioAge Labs has completed its upsized initial public offering (IPO), raising $198 million after increasing the number of shares on offer by 40%. The expansion of the listing reflects the massive investor appetite for companies with assets in the clinic for obesity and takes the on-paper value of the Richmond, California-based company above $600 million.
Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.
Patients who received higher doses of buprenorphine, a common medication used to alleviate opioid withdrawal and cravings, were less likely to be hospitalized and less likely to discontinue treatment, according to a new study. The findings run counter to federal guidelines about buprenorphine dosing. Currently, the Food and Drug Administration recommends a target dose of 16 mg.
Flagship Pioneering's latest biotech launch, Mirai Bio, aims to help genetic medicine developers find the best way to get their drugs to patients.The new Cambridge, Massachusetts-based company – which was set up in 2021 but makes its official launch today with $50 million in funding from Flagship – applies artificial intelligence to solve the various obstacles that can block the progress of new medicines.
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. Good morning! Exactly one year ago today, STAT published stories on suicide risk among nurses, the fight from dairy farmers to kill the terms “ oat milk ” and “soy milk,” and the final decision on where ARPA-H would be headquartered.
Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.
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